Investigators are referred to the IRB Manual for information pertaining to the required elements of informed consent, format for informed consent forms, special consent circumstances and waiver of informed consent. The Office of Human Research Protection (OHRP) has provided the following video links that investigators may find useful when planning clinical studies and patient interviews for the purpose of obtaining informed consent and for the latest changes to the Common Rule as it pertains to informed consent.
General Informed Consent Requirements begins with a short meeting between an investigator and an IRB member regarding the requirements for obtaining informed consent for a proposed study on the effects of a test drug on cognitive function in schizophrenic patients. Issues pertaining to capacity to consent and obtaining consent from a legally authorized representative are discussed. The video continues with an interview between the investigator and a prospective subject in which the investigator explains the study and the patient’s rights, giving the subject an opportunity to ask questions.
Complex Issues with Research Involving Vulnerable Populations is a question and answer session between representatives from OHRP and audience members. Topics discussed include human subjects research involving patients with diminished capacity to give informed consent; research involving prisoners, minors, non-English speaking populations, and emergency research on vulnerable populations.
What’s New in Informed Consent: Revisions to the Common Rule [July 12, 2018] discusses the general improvements to informed consent. It begins with a case involving a woman with breast cancer who underwent surgery and chemotherapy. The clinical trial was to determine if adding radiation therapy would reduce the risk of breast cancer reoccurrence. However, the informed consent made no mention as to whether or not minimizing the risk of the cancer reoccurring would actually increase the chance of survival. Other topics covered in the video include:
- Using the “Reasonable Person” standard to decide what information to include in the informed consent;
- Possible future use of data stripped of identifiers;
- Possible commercial profit;
- If clinically relevant research results will be given to the study subjects;
- If the research will include whole genome sequencing;
- Posting of a clinical trial consent form;
- Use of a legally authorized representative;
- Future use of identifiable biospecimens for unspecified future research.
Broad Consent in the Revised Common Rule [June 22, 2018] discusses an option called “Broad Consent” that is intended to facilitate minimal risk research and allow subjects to permit secondary research use of identifiable private information or biospecimens for future unspecified research. It further explains the differences between Broad Consent and existing options for conducting secondary research and the limitations on the use of Broad Consent that might not make it the preferred option.